Cerebral Oxymetry and Neuronal Biomarkers in Newborns and Infants During Perioperative Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- change in S-100B and NSE concentrations in serum
研究概览
简要总结
The purpose of this study is to assess whether peri-operative period in neonates and infants is associated with an increase in blood biomarkers, specific for neuronal injury, and to correlate them with clinical variables and sedative/analgesic agents. Patients, who meet inclusion criteria and does not meet exclusion criteria, are enrolled. Blood samples for measurement serum concentrations of markers (S100-B and Neuron-Specific Enolase (NSE)) are drawn before surgery (baseline) and on the 1-st, 2-nd and 3-rd day after surgery. During surgery cerebral oxygenation (rSO2) monitoring is continuously applied; rSO2, hemodynamic and respiratory values are simultaneously recorded every 5 minutes. Anesthesia, pre and postoperative treatment, including analgesia and sedation, are given as per standard of care.
详细描述
Retrospective studies have shown that surgery in infancy is associated with worse neurodevelopmental outcome, compared to general population. The reasons may be complex, and patients at risk are unknown. Brain growth and central nervous system formation are extremely active in neonates and infants. Metabolic or circulatory derangement may have negative influence on the developing brain. Disease and perioperative period, both may further put this population at risk for physiological abnormalities. Near infrared spectroscopy was shown to be a convenient method for monitoring of cerebral tissue oxygenation during surgery.
The great majority of anesthetics and sedative drugs, used in perioperative period, were shown to cause neuronal apoptosis in experimental animals. Some studies found that neurological marker S-100B increased in cerebrospinal fluid and blood immediately following anesthesia in animals. Several clinical studies supported this founding in children following cardiac and general surgery.
The aim of this study is to assess the dynamics of S-100B protein pre- and during 72 hours after surgery in neonates and infants aged 1-93 days, operated for abdominal/thoracic/urologic malformations/disease. As S-100B in blood may have extracranial sources, we simultaneously assess other neuronal marker Neuron-specific Enolase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- — 至 93 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients, undergoing general, thoracic, urological surgery for congenital anomalies or disease
- •signed written informed consent by parents/official caregivers
排除标准
- •cardiac surgery
- •any evidence of neurological disease
- •limited ability to obtain blood samples
- •clinically significant anemia
- •physical status of the patients corresponding to American Society of Anesthesiologists (ASA) class 4 and 5.
结局指标
主要结局
change in S-100B and NSE concentrations in serum
时间窗: within 24 hours and 3 days after surgery
change in S-100B and NSE concentrations in serum compared to preoperative value
次要结局
- association of S-100B and NSE concentrations in serum with intraoperative cerebral near infrared spectroscopy values.(within 24 hours after surgery)
研究者
Danguole C Rugyte
MD, PhD.
Lithuanian University of Health Sciences